(1)
in Article 6, paragraph 3 is replaced by the following: ‘3. The Commission is empowered to adopt delegated acts in accordance with Article 6a amending this Directive in order to resolve the matters referred to in paragraph 1. Amendments to Annex I shall not change its nature of providing guidance for compliance monitoring procedures for GLP and for the conduct of test facility inspections and study audits.’;
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Source: EUR-Lex (Cellar) · retrieved 2026-10-13 · Text as adopted (Official Journal); later amendments are not incorporated in this text.